FDA 510(k) Application Details - K100351

Device Classification Name Wire, Guide, Catheter

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510(K) Number K100351
Device Name Wire, Guide, Catheter
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact JOAN BARTLE
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 02/12/2010
Decision Date 03/16/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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